Thousands of cans of infant formula have been recalled in 12 states because they contained more than the maximum allowable amount of vitamin D, according to the Food and Drug Administration (FDA).
The product, Perrigo Premium Infant Formula, which uses a milk-based powder with iron, was voluntarily recalled by the Michigan-based company on Thursday, August 8.
The recall affects three lots in one batch, or 16,500 cans.
The powdered milk was being distributed to HEB Grocery in Texas and CVS in California, Florida, Indiana, Michigan, Missouri, New Jersey, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas and Virginia.
No other products or retailers are affected by this recall, and there have been no reports of adverse health effects due to elevated levels of vitamin D in the products. The FDA said the excess levels were discovered during routine testing.
Newsweek reached Perrigo by phone Friday morning for comment.
Stock image of a person holding a baby bottle. Thousands of cans of Perrigo infant formula have been recalled in 12 states. Stock image of a person holding a baby bottle. Thousands of cans of Perrigo infant formula have been recalled in 12 states. Eric Gay/AP
According to the FDA, short-term consumption of products with the affected lot codes is “unlikely to cause adverse health effects” for most infants. However, for a small percentage of physiologically vulnerable infants, consuming the recalled products may cause health problems.
According to the Centers for Disease Control and Prevention (CDC), children need vitamin D to build strong bones early in life. Babies who are breastfed exclusively or who drink both breast milk and formula need a 400 IU vitamin D supplement per day, while babies who drink only formula don't need a supplement because their formula is fortified with vitamin D.
The lot code and “use by” date that parents or guardians who purchased the recalled products should check can be found on the bottom of the packaging. The lot codes and “use by” dates for products shipped to CVS beginning Feb. 6 are as follows: T11LMYC – Use through November 11, 2025.
These are for products being distributed to HEB Grocery Company, LB starting February 2nd: T11LMXC – Use through November 11, 2025. T09LMXC – Use through November 9, 2025.
The agency encouraged parents or guardians to report any symptoms to FDA's MedWatch Adverse Event Reporting Program online at www.fda.gov/medwatch/report.htm and to contact their health care provider if an infant experiences any symptoms while using the product.
In 2022, FDA safety concerns led to the closure of a key facility in Sturgis, Michigan, and several recalls due to bacterial contamination, exacerbating nationwide shortages due to supply issues related to the pandemic.
Millions of parents struggled to find formula and many were forced to switch brands, which had adverse effects on their babies.
Updated Aug. 9, 2024 at 10:51 a.m.: This story has been updated with additional information.
